Blood plasma serves as key raw material in blood product industry. In August 2011, the shut-down of 16 plasma collection stations in Guizhou province, China resulted in a YoY decline of 15% in plasma volume and further intensified the tight supply of raw material plasma. But when it comes to the lot release volume, the blood product output in China grew as high as 15.4% YoY in 2011, and the market size rose 22% YoY to around RMB11.6 billion. Additionally, in consideration of 12th Five-Year Plan for Doubling Blood Product Supply proposed by the Minister of the Ministry of Health at the end of 2011, the issuance of Notice of the Ministry of Health on Management of Plasma Collection Stations in early 2012, and the domestic market demand & supply, the blood product market size in China is expected to maintain a high growth rate of over 20% in the five years to come.

However, the low degree of industry concentration, the companies’ weak R&D capabilities, short supply of raw material plasma and low plasma utilization rate affect the development of Chinese blood product industry to some extent. The blood products released in overseas market divide into around 40 varieties, and the international blood product giants can extract about 15 varieties of blood products from plasma, while among Chinese companies, Beijing Tiantan Biological Products Co., Ltd. can produce at most 11 varieties from plasma. Moreover, Chinese blood product market is principally concentrated on human albumin and human immunoglobulin (pH4) for intravenous injection which pose low requirements on technologies. In 2011, the lot release volume of the two products made up 53.4% and 16.8% of the total release volume respectively.

Blood coagulation factor and thrombin products feature the largest demand gap in China, but there are less domestic supply and fewer producers. In 2011, the manufacturers of Human Coagulation Factor VIII in China just include Shanghai RAAS Blood Products, Green Cross China and Hualan Biological Engineering Inc., with lot release volume adding up to 350,000 bottles, and the producers of Human Prothrombin Complex are Hualan Biological Engineering Inc., Shanghai RAAS Blood Products and Shanghai Xinxing Medicine, with lot release volume totaling 200,000 bottles. Essentially, subsidiaries under China National Biotech Group and other Groups that possess production capacity and obtain governmental approvals in Coagulation Factor VIII and IX do not conduct production in recent years. With the intensifying contradiction between supply and demand, the government may launch intervention measures to enable the enterprises with the approval to restart the manufacturing of these products to raise overall supply of products of this sort.

Although taking such factors like home market demand into account, China has allowed the import of some blood products, but the imports are confined to human albumin and recombinant coagulation factor. Moreover, blood product manufacturing is a sector with no allowance for foreign capital. The imported human albumin almost makes up 50% market share, and the proportion reached 43.3% in 2011.

Following the tougher conflict between supply & demand and the loosening of policies in China, foreign brands quicken their pace of tapping into Chinese market. In May 2012, SFDA approved the release of Baxter’s ADVATE (Recombinant Human Coagulation Factor VIII for injection) in China which was another foreign brand of coagulation factor after the imported Bayer’s Recombinant Coagulation Factor VIII in 2007. Moreover, Pfizer is applying for quick approval program for its Recombinant Coagulation Factor IX (obtained from Wyeth).